Label: FEMICLEAR BACTERIAL VAGINOSIS SYMPTOMS- thymol with olive extract ointment
- NDC Code(s): 71042-025-14
- Packager: Organicare Nature's Science, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated October 12, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Ask a doctor before use if you have:
- vaginal itching and discomfort for the first time
- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition.
- bacterial vaginosis often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS.
- Do not use
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When using this product
- do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted infections (STIs)
- do not have vaginal intercourse
- mild increase in vaginal burning, itching, or irritation may occur
- if you do not get relief, consult a doctor
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of the reach of children
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Directions
Adults and children 12 years of age and older:
- Use at bed time, read enclosed instructions for complete directions.
- to protect clothes, use a panty liner.
- fill applicator with Vaginal Ointment - use 1/2 of the tube
- lie down in bed. Insert applicator into vagina and inject ointment. Remain lying down to avoid leakage.
- discard applicator after use. DO NOT reuse.
- repeat on second night - use other 1/2 of the tube
Children under 12 years: ask a doctor
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Other Information
- do not use if applicator wrapper is torn, open or incompletely sealed
- do not use if seal over tube opening has been punctured
- Store at 68°-77°F (20°C - 25°C) If liquified, refrigerate 10 minutes to thicken.
- this is a 2-dose treatment. Most women do not get complete relief of their symptoms in just 2 days.
Most women get some improvement in 2 days and complete relief by 7 days.
- Inactve ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FEMICLEAR BACTERIAL VAGINOSIS SYMPTOMS
thymol with olive extract ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71042-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 6 [hp_X] in 100 g OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN 3 [hp_X] in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) OLIVE OIL (UNII: 6UYK2W1W1E) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71042-025-14 1 in 1 CARTON 06/01/2022 1 14.2 g in 1 TUBE; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2022 Labeler - Organicare Nature's Science, LLC (044204745) Registrant - Organicare Nature's Science, LLC (044204745) Establishment Name Address ID/FEI Business Operations Organicare Nature's Science, LLC 044204745 manufacture(71042-025)
